Product NDC: | 58914-301 |
Proprietary Name: | Rectiv |
Non Proprietary Name: | nitroglycerin |
Active Ingredient(s): | 4 mg/g & nbsp; nitroglycerin |
Administration Route(s): | RECTAL |
Dosage Form(s): | OINTMENT |
Coding System: | National Drug Codes(NDC) |
Product NDC: | 58914-301 |
Labeler Name: | Aptalis Pharma US, Inc. |
Product Type: | HUMAN PRESCRIPTION DRUG |
FDA Application Number: | NDA021359 |
Marketing Category: | NDA |
Start Marketing Date: | 20110621 |
Package NDC: | 58914-301-80 |
Package Description: | 1 TUBE in 1 CARTON (58914-301-80) > 30 g in 1 TUBE |
NDC Code | 58914-301-80 |
Proprietary Name | Rectiv |
Package Description | 1 TUBE in 1 CARTON (58914-301-80) > 30 g in 1 TUBE |
Product NDC | 58914-301 |
Product Type Name | HUMAN PRESCRIPTION DRUG |
Non Proprietary Name | nitroglycerin |
Dosage Form Name | OINTMENT |
Route Name | RECTAL |
Start Marketing Date | 20110621 |
Marketing Category Name | NDA |
Labeler Name | Aptalis Pharma US, Inc. |
Substance Name | NITROGLYCERIN |
Strength Number | 4 |
Strength Unit | mg/g |
Pharmaceutical Classes | Nitrate Vasodilator [EPC],Nitrates [Chemical/Ingredient],Vasodilation [PE] |